Know Cancer

or
forgot password

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer


Inclusion Criteria:



- Stage I-IIIa breast cancer

- Postmenopausal

- Recent surgery for breast cancer

Exclusion Criteria:

- Metastatic disease

- Invasive bilateral disease

- Clinical or radiological evidence of existing fracture in spine or hip

Other protocol-defined inclusion / exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy

Outcome Description:

Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.

Outcome Time Frame:

From Baseline - 12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

CFEM345D2406

NCT ID:

NCT00171314

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • letrozole
  • zoledronic acid
  • adjuvant
  • postmenopausal
  • Breast Neoplasms

Name

Location